Dupilumab for Eosinophilic Gastrointestinal Diseases

(ENGAGE Trial)

Not currently recruiting at 89 trial locations

Overseen By Clinical Trials Administrator

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Weight < 40 kg, Helicobacter pylori, Crohn's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called dupilumab (also known as Dupixent) to determine its effectiveness for people with eosinophilic gastritis (EoG), a condition where certain white blood cells cause stomach inflammation. The trial aims to assess whether dupilumab can reduce symptoms and inflammation in the stomach, and possibly the small intestine, over 6 months to a year. Researchers also seek to understand any side effects, how the drug moves in the body, and if the body develops resistance to it. Individuals may qualify for this trial if they have frequent EoG symptoms (with or without eosinophilic duodenitis, EoD), confirmed by a doctor, and have experienced these symptoms at least twice a week recently. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that the use of any prohibited medications during the study is not allowed. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that dupilumab is likely to be safe for humans?

Research shows that dupilumab may help treat conditions like eosinophilic gastritis (EoG) by reducing inflammation. In earlier studies, patients with eosinophilic esophagitis, a similar condition, experienced significant improvements with dupilumab compared to those who took a placebo. These studies also suggest that dupilumab is generally safe for patients.

Although the FDA has not yet approved dupilumab specifically for EoG, its use in treating other similar conditions provides some confidence in its safety. This trial is in an early stage and primarily aims to assess the safety of dupilumab for people with EoG. Participants in similar studies have mostly reported mild side effects. However, like any medical treatment, risks exist, and researchers will closely monitor any potential side effects during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for eosinophilic gastrointestinal diseases, which often involve dietary changes or corticosteroids, Dupilumab is unique because it specifically targets and blocks the IL-4 and IL-13 pathways. These pathways are key players in the inflammation process associated with eosinophilic conditions. By targeting these pathways, Dupilumab offers a more precise approach to reducing inflammation and symptoms. Researchers are excited about this treatment because it has the potential to provide more effective and sustained relief with fewer side effects compared to traditional therapies.

What evidence suggests that dupilumab might be an effective treatment for eosinophilic gastritis?

Research shows that dupilumab, which participants in this trial will receive, may help treat eosinophilic gastritis (EoG). One study showed that dupilumab improved the appearance and function of the stomach lining in people with EoG. Another study found that patients experienced fewer swallowing difficulties and reduced stomach inflammation. Dupilumab is already approved for treating eosinophilic esophagitis (EoE), a similar condition. These findings suggest that dupilumab can help reduce symptoms and inflammation in people with EoG. ^{2 4 6 7 8}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Adults and adolescents aged 12+ with active eosinophilic gastritis (EoG), not just duodenitis, can join this trial. They must have a history of EoG symptoms, documented diagnosis, and meet specific symptom severity scores. Exclusions include Helicobacter pylori infection, certain dietary changes before screening, major upcoming surgery, other gastric conditions like Crohn's disease or past dupilumab use.

Inclusion Criteria

I've had at least 2 episodes of gastrointestinal symptoms weekly in the last 8 weeks.

My symptom scores have been high for the past 2 weeks.

Completed at least 11 of 14 days of EoG/EoD-SQ eDiary data entry in the 2 weeks prior to the baseline visit

Exclusion Criteria

My body weight is under 40 kg.

I have previously participated in a dupilumab trial or have been treated with dupilumab.

I am currently on tube feeding or IV nutrition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A or B

Participants receive either dupilumab or placebo in a 24-week double-blind phase

24 weeks

Part C

28-week extension where all participants receive dupilumab

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The study tests the safety and effectiveness of an experimental drug called dupilumab in two different doses compared to a placebo for treating EoG with or without EoD. It will also examine how much drug is in the blood over time and if the body creates antibodies against it.

How Is the Trial Designed?

Group I: Dupilumab Experimental Treatment 1 Intervention

Part A: Treatment Period Part C: Extended Treatment Period Eligible participants from Part A will enter Part C

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

In a real-life study of 12 patients with severe type-2 asthma, dupilumab treatment for 3 months led to significant improvements in asthma control (ACT score) and lung function (FEV1), indicating its efficacy in managing symptoms.

The treatment also resulted in a notable reduction in FeNO levels, a biomarker for type-2 inflammation, although blood eosinophil counts did not show significant change, suggesting that dupilumab effectively targets the IL4/IL13 pathway in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. Carpagnano, GE., Scioscia, G., Buonamico, E., et al.[2022]

Dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, showed promising results in achieving clinical and histopathologic remission in three pediatric patients with non-eosinophilic esophagitis gastrointestinal disorders (EGID) who did not respond to standard treatments.

This study suggests that dupilumab may be a potential new treatment option for pediatric patients with eosinophilic gastrointestinal disorders, as it effectively reduced mucosal eosinophilia in multiple segments of the gastrointestinal tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Series on the Use of Dupilumab for Treatment of Refractory Eosinophilic Gastrointestinal Disorders. Patel, N., Goyal, A., Thaker, A., et al.[2023]

Dupilumab is an effective monoclonal antibody treatment for several conditions, including chronic rhinosinusitis with nasal polyposis and asthma, highlighting its broad therapeutic applications.

While generally well-tolerated, dupilumab can cause delayed hyperpigmented injection site reactions, in addition to more common temporary injection site and ocular surface reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed Hyperpigmented Injection Site Reactions Due to Chronic Dupilumab Use. Pacheco, CS., White, KM.[2023]

In a review of 22 studies involving 3303 patients, dupilumab demonstrated significant efficacy in treating atopic dermatitis, with 85.1% of patients achieving at least a 50% improvement in their Eczema Area and Severity Index (EASI) score after 16 weeks of treatment.

While dupilumab is generally well-tolerated, conjunctivitis was the most common side effect, occurring in 26.1% of patients, highlighting the need for ongoing monitoring of adverse events in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence of dupilumab efficacy and risk of adverse events: A systematic review and meta-analysis. Halling, AS., Loft, N., Silverberg, JI., et al.[2021]

Dupilumab is an effective treatment for type 2 inflammatory diseases like atopic dermatitis, asthma, and nasosinusal polyposis, as it inhibits the IL-4 receptor, blocking the action of key cytokines involved in these conditions.

The drug has a favorable safety profile, with few and reversible side effects, making it a promising option for patients who do not respond well to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. Russo, G., Laffitte, E.[2023]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

Dupilumab, a monoclonal antibody used to treat conditions like asthma and atopic dermatitis, can cause hypereosinophilia (high eosinophil levels) as a potential adverse effect, which poses a challenge for clinicians.

An algorithm has been proposed to help manage dupilumab-induced hypereosinophilia, allowing for proper investigation of related health issues while minimizing unnecessary discontinuation of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab-induced hypereosinophilia: review of the literature and algorithm proposal for clinical management. Caminati, M., Olivieri, B., Dama, A., et al.[2022]

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, effectively inhibiting the action of IL-4 and IL-13, which are key players in allergic diseases.

It received its first approval in March 2017 for treating moderate-to-severe atopic dermatitis in adults who do not respond well to topical treatments, and is also being developed for asthma, nasal polyps, and eosinophilic esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: First Global Approval. Shirley, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656811/

Effective use of dupilumab for eosinophilic gastritis ... This case report supports that dupilumab could be an effective treatment option for EoG and accompanying severe asthma.

2. congress.sanofimedical.com congress.sanofimedical.com/s3fs-public/2025-04/Dupilumab%20Improves%20Multiple%20Outcomes%20in%20Adults%20and%20Adolescents%20with%20Eosinophilic%20Gastritis%20%28EoG%29.pdf?VersionId=CZ0_va_zE98gCRwb2nBO0mcgpKZdQQcC

Dupilumab Improves Multiple Outcomes in Adults and ... Gonsalves NP, et al. Dupilumab improves histologic and endoscopic features of eosinophilic gastritis: Results from the multicenter, randomized, double-blind, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05831176

NCT05831176 | A Study to Learn How Well Dupilumab ... The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if ...

4. gi.org gi.org/journals-publications/ebgi/eluri_dec2024/

Long Term Efficacy and Safety of Dupilumab for ... Weekly dupilumab significantly reduced dysphagia symptoms, with a mean DSQ score improvement of –30.3 points, and decreased peak eosinophil ...

5. dupixent.com dupixent.com/eoe/

DUPIXENT® (dupilumab) For Eosinophilic Esophagitis DUPIXENT is a prescription medicine used to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06693531?term=NCT06693531&rank=1

A U.S. Registry of Eosinophilic Esophagitis Adolescent and ... This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38924731/

Dupilumab for Eosinophilic Esophagitis in Patients 1 to 11 ... Dupilumab resulted in histologic remission in a significantly higher percentage of children with eosinophilic esophagitis than placebo.

8. trial.medpath.com trial.medpath.com/clinical-trial/59967276b3fcf825/jrct2031230539-dupilumab-safe-adolescent-eosinophilic-gastritis

A Trial to Learn if Dupilumab is Safe for and Helps Adult and ... A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis ( ...